503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility adheres to the highest current good manufacturing practices (cGMP) mandated by the FDA for sterile and non-sterile drug production. This rigorous regulatory framework ensures that every preparation leaving the facility meets stringent standards for potency, purity, and sterility, providing healthcare providers and patients with a level of confidence in the quality of their compounded medications.
The core function of this 503B outsourcing facility is the large-scale compounding of medications that are distributed for office use by healthcare practitioners. This means physicians, surgeons, veterinarians, and other medical professionals in need of bulk, ready-to-administer medications for their practice can rely on 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 as a trusted source. The facility is equipped to produce significant quantities of compounded preparations, which are essential for clinics, hospitals, and surgical centers that require a consistent and reliable supply of specific formulations not readily available from commercial pharmaceutical manufacturers.
By operating under Section 503B, this facility provides a vital service to the medical community. It helps mitigate drug shortages by compounding critical medications that are otherwise on backorder or discontinued. It also creates essential patient-specific formulations that are not commercially available, such as specific strengths or dosage forms, or medications free of certain allergens like dyes or preservatives. All processes at the 2160 W State Road 434, Longwood, FL 32779 location are conducted under a state-of-the-art controlled environment by highly trained personnel, ensuring the integrity and safety of every preparation. For healthcare providers seeking a compliant and quality-focused source for office-use compounded medications, 503B Compounding Pharmacy stands as a pivotal partner.
To learn more about the services provided or to place an order, healthcare entities can contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Additional information may also be available through their official website at .
Frequently Asked Questions
1. What does it mean that you are a 503B outsourcing facility?
It means our operation at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and strictly follows current good manufacturing practices (cGMP). This regulatory status allows us to compound large volumes of medications for office use by healthcare providers, ensuring they meet the highest standards for safety and quality.
2. Can I as an individual patient pick up my prescription at your location?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications in bulk for office use by licensed healthcare practitioners. Individual patient prescriptions are typically compounded and dispensed by traditional 503A compounding pharmacies based on a patient-specific prescription.
3. What types of medications do you compound at your Longwood facility?
At our facility located at 2160 W State Road 434, Longwood, FL 32779, we compound a wide range of sterile and non-sterile preparations in larger quantities. This includes but is not limited to hormonal preparations, sterile injectables, ophthalmics, and other formulations needed by healthcare practices in the area.
4. How do I, as a healthcare provider, order from your facility?
Healthcare providers can place orders for office-use compounded medications by contacting our facility directly at (407)993-1381. Our team will assist with setting up an account and processing your order, which can be shipped or made available for pick-up at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a medical practice choose a 503B outsourcing facility like yours?
Choosing our 503B outsourcing facility ensures that the medications you use in your practice are produced under the most rigorous FDA cGMP standards. This provides a critical layer of safety and quality control, reduces the risk of compounding errors, and ensures consistency and reliability in the medications you administer to your patients.